Agency Authorizes First OTC All-in-One At-Home COVID-19 Testing Kit

Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for home collection of samples. On Nov. 17, the agency broke new ground by clearing Lucira Health’s COVID-19 All-in-One Test Kit, the first all-in-one COVID-19 diagnostic enabling people to test themselves in their own home to receive EUA. On Dec. 15, the agency went one step further by issuing EUA for a full at-home testing kit for the virus that does not require a prescription.

The Ellume COVID-19 Home Test

The distinction of being the first went to the Ellume COVID-19 Home Test, is a rapid antigen test capable of detecting fragments of the SARS-CoV-2 virus. Although the assay is performed on samples taken from nasal swabs, it is a nasal mid-turbinate (NMT) test, which makes it less invasive than tests performed on samples taken using the much longer nasopharyngeal (NP) swabs that require a trained a health care provider to administer.

More significantly, it is an over-the-counter rather than a prescription test. Accordingly, FDA Commissioner Stephen M. Hahn, MD, hailed the approval as “a major milestone” in COVID-19 testing. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” Hahn suggests.

Costing about $30, the Ellume test kit includes a sterile nasal swab, dropper, processing fluid, and a Bluetooth-connected “Analyzer,” that pairs with an app providing step-by-step video instructions that users can upload to their smartphone. Step-by-step video instructions for taking the test are provided on the app. After the sample is analyzed, results are delivered to the user’s smartphone via Bluetooth in 15 minutes or less.

The test is pretty accurate, having correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms, according to the FDA. The test also correctly identified 91 percent of positive samples and 96 percent of negative samples in asymptomatic persons.

However, because antigen tests are generally prone to both false negative and positive results, the FDA recommends that patients who are not displaying COVID-19 symptoms treat positive results as “presumptively positive until confirmed by another test as soon as possible.” This is likely to be particularly relevant for communities with fewer infections, because false positive results can be more common when antigen tests are used in populations where there is low prevalence of COVID-19.

Here are the other key new FDA EUAs and clearances announced in December:

New FDA Emergency Use Authorizations (EUAs) & Approvals